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510(k) Data Aggregation
K Number
K964625Manufacturer
Date Cleared
1997-05-05
(171 days)
Product Code
Regulation Number
870.3450Type
TraditionalPanel
CardiovascularReference & Predicate Devices
N/A
Why did this record match?
Device Name :
HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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